Description

Iso Ribavirin (Ribavirin Impurity G) is a specified impurity of the broad-spectrum antiviral drug Ribavirin. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Ribavirin active pharmaceutical ingredients (APIs) and finished dosage forms. It is primarily required by analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and biotechnology industries to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Iso Ribavirin in Ribavirin API and drug products.
• Analytical Method Development & Validation: Essential for developing, validating, and transferring HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Stability Studies: Used in routine QC testing and forced degradation studies to monitor impurity levels and ensure batch-to-batch consistency.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Pharmacopoeial Testing: Employed in testing to meet the stringent impurity limits specified in pharmacopoeias such as USP, EP, and BP.
• Research on Degradation Pathways: Aids in studying the stability and degradation mechanisms of Ribavirin under various environmental conditions.

Basic Information

Product Name	Iso Ribavirin (Ribavirin Impurity G)
CAS No.	39030-43-8
Molecular Formula	C8H12N4O5
Molecular Weight	244.21 g/mol
Synonyms	1-((2R,3R,4S,5R)-3,4-Dihydroxy-5-(hydroxymethyl)oxolan-2-yl)-1H-1,2,4-triazole-3-carboxamide; 1-β-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide; Ribavirin Isomer; Ribavirin Related Compound G; Ribavirin EP Impurity G; Ribavirin USP Related Compound G
EINECS	Contact for details

Quality Control

Every batch of Iso Ribavirin (Ribavirin Impurity G) is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, NMR, and mass spectrometry to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.